Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
510(k) Number K003075
Device Name KNIGHTSTAR 330 VENTILATOR
Applicant
Mallinckrodt, Inc.
675 Mcdonnell Blvd.
Bldg. 10-2-N
St. Louis,  MO  63134
Applicant Contact ANTHONY MULLIN
Correspondent
Mallinckrodt, Inc.
675 Mcdonnell Blvd.
Bldg. 10-2-N
St. Louis,  MO  63134
Correspondent Contact ANTHONY MULLIN
Regulation Number868.5895
Classification Product Code
MNT  
Date Received10/03/2000
Decision Date 12/11/2001
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-